Vedolizumab – Frequently asked Questions & Answers

This information has been provided with kind permission from Crohn’s and Colitis UK – a nationwide charity committed to providing information and support, funding crucial research and working to improve healthcare services for anyone affected by Inflammatory Bowel Disease.

Vedolizumab is a biological drug. You may also hear it called by the brand name Entyvio.

WHY AM I BEING TREATED WITH THIS MEDICINE?

Vedolizumab is used to treat adults over the age of 18 with moderate to severe Crohn’s Disease or Ulcerative Colitis. If you have Ulcerative Colitis, vedolizumab may be an option for you if other treatments such as steroids, 5-ASAs and immunosuppressants have not helped your condition. It also may be an option if you have tried another group of medicines called ‘anti-TNF drugs’ (such as infliximab or adalimumab) but they did not help your condition. If you have Crohn’s Disease, vedolizumab may be an option if you have tried an anti-TNF and it did not help your condition, or you are not able to take anti-TNF drugs because of your medical history. In some circumstances, for both Ulcerative Colitis and Crohn’s Disease, your doctor may suggest trying vedolizumab before other treatments. At the moment, there is not enough research about vedolizumab as a treatment for IBD in children, and using it in children is not included in its licence, the document that explains what a medicine will be used for. Even so, if you are under 18 and other treatments have not helped your condition, your IBD team may discuss whether vedolizumab might be an option for you.

HOW DOES IT WORK?

Vedolizumab belongs to a group of medicines called ‘biological drugs.’ Biological drugs are made from proteins and other substances that occur in nature. They are produced by a biological rather than chemical process – for example they can be created inside living cells. Vedolizumab is a ‘gut-selective integrin blocker’ that targets white blood cells. White blood cells are made by the immune system to fight infection. In Crohn’s Disease and Ulcerative Colitis, overproduction of these cells leads to inflammation. Vedolizumab works by stopping the white blood cells from entering the lining of the gut. This means that the drug only targets the gut, rather than the whole of the body like anti-TNF drugs, and may cause fewer side effects.

HOW LONG WILL IT TAKE TO WORK?

Everyone responds differently to vedolizumab. Some people may start feeling better within six weeks, but it may take longer. If you have Crohn’s Disease, vedolizumab may take up to 14 weeks to work.

HOW DO I TAKE VEDOLIZUMAB?

Vedolizumab is given as an intravenous (IV) infusion – that is, through a drip into a vein in your arm. It cannot be taken orally (in tablet form), because your digestive system would destroy it. A trained member of staff, normally a nurse or a doctor, will give you infusions of vedolizumab in hospital. You will probably be treated as a day patient, unless you are already in hospital. You will be able to have the infusion while sitting in a chair, so you won’t have to undress, get into bed or stay overnight. Your team will observe you closely during your infusion. For your first two infusions, they will also monitor you for approximately two hours after the infusion has finished. After the first two infusions, you will only need to stay for about an hour after you have completed the infusion. The infusion itself takes only 30 minutes. It is likely to vary a little, but your whole treatment session may take up to two or three hours in total, including getting ready for the infusion and monitoring afterwards. Treatment time might reduce once you are having regular or maintenance infusions (see below). Check with your IBD team to find out how long you may need to be in hospital.

WHAT IS THE NORMAL DOSAGE AND HOW OFTEN WILL I NEED AN INFUSION?

You will have a 300mg dose of vedolizumab during each infusion. To begin with, you will have a series of ‘starter’ infusions during the first six weeks:

• You’ll have your first dose,
• then another two weeks later,
• and then another six weeks after the first one.

If you have Crohn’s Disease and you are not improving after your third starter infusion of vedolizumab, your doctor may feel it is valuable for you to have an additional starter dose at week 10. If you respond well to the treatment, it is likely you will start a maintenance programme of infusions every eight weeks. If your symptoms do not seem to be improving, your doctor may increase your vedolizumab treatment to infusions every four weeks to see if that helps. If vedolizumab does not seem to be helping with your symptoms at all, your IBD team may advise stopping treatment:

• after 10 weeks if you have Ulcerative Colitis
• after 14 weeks if you have Crohn’s Disease

Sometimes your IBD team may recommend that you try vedolizumab for a bit longer to see if it does start to have an effect.

HOW EFFECTIVE IS VEDOLIZUMAB?

Although not everyone responds to vedolizumab, research has shown that vedolizumab can be effective in improving symptoms and bringing about and maintaining remission in people with moderate to severe Crohn’s Disease and Ulcerative Colitis. It may also mean you don’t have to take steroids.

DOES VEDOLIZUMAB AFFECT PREGNANCY AND FERTILITY?

The effects of vedolizumab during pregnancy are not yet known. Taking vedolizumab while you’re pregnant is not currently recommended, unless you and your IBD team have decided that the benefits of taking it strongly outweigh any risks to you and your baby. If you are a woman who could get pregnant, you should use effective contraception while you’re having treatment, and keep using it for at least 5 months after your treatment has finished. If you are planning a pregnancy, please discuss this with your IBD team first, and if your pregnancy is unplanned, notify your IBD team as soon as possible. There has not been any research about whether vedolizumab has an effect on male fertility. If you are worried about this, ask your IBD team for advice.

This information is designed to answer common questions you may have if you have been given azathioprine or mercaptopurine to treat your Crohn’s Disease or Ulcerative Colitis, the two main forms of Inflammatory Bowel Disease (IBD). It is not intended to replace specific advice from your own doctor or any other health professional. You can obtain further information from your doctor, pharmacist, the information leaflet supplied with your medication or from the website: http://www.medicines.org.uk

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This information has been provided with kind permission from Crohn’s and Colitis UK – a nationwide charity committed to providing information and support, funding crucial research and working to improve healthcare service for anyone affected by Inflammatory Bowel Disease.

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The information on this site is for guidance only. It is not a substitute for professional medical care by a qualified doctor or other health care professional. Always check with your doctor if you have any concerns about your condition or treatment.